Clearance Summary
VALIDATE Anemia Calibration Verification/ Linearity Test Kit received FDA 510(k) clearance under submission number K142964, sponsored by Maine Standards Company, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2015-04-30.
- Submission: K142964
- Applicant / Sponsor: Maine Standards Company, LLC
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1660
- Decision date: 2015-04-30
Classification & Regulation
This clearance is catalogued under FDA product code JJY and 21 CFR 862.1660, within the Clinical Chemistry review panel as a Class I device.